This invention is a device for bridging the neck of either a wide-necked or narrow-necked aneurysm in the vasculature and stabilizing the presence of vaso-occlusive devices (such as helically wound coils) in that aneurysm. The retainer assembly may be delivered from its attachment to the distal end of a tubular member preferably by the severance of by an included electrolytically severable joint. The retainer assembly itself typically has a number of array elements which are intended to be resident within the aneurysm after the device is deployed from the distal end of a catheter. After deployment of this retainer, the aneurysm is at least partially filled with a vaso-occlusive device such as helically wound coils.
Different implantable medical devices have been developed for treating a number of ailments associated with body lumens. In particular, occlusive devices are useful in filling vascular or other body spaces. Some body spaces, such as vascular aneurysms, are formed due to a weakening in the wall of an artery. Often these aneurysms are the site of internal bleeding and stroke. A variety of different embolic agents are known as, at least arguably, suitable for treatment of these anomalies. These treatments are commonly known as xe2x80x9cartificial vaso-occlusion.xe2x80x9d
One such class of embolic agents includes indictable fluids or suspensions, such as microfibrillar collagen, various polymeric beads, and polyvinylalcohol foam. These polymeric agents may additionally be crosslinked, sometimes in vivo, to extend the persistence of the agent at the vascular site. These agents are often introduced into the vasculature through a catheter. After such introduction, the introduced materials there form a solid space-filling mass. Although some provide excellent short term occlusion, many are thought to allow vessel recanalization due to absorption of polymer into the blood. Another procedure in which a partially hydrolyzed polyvinylacetate (PVA) is dissolved in an ethanol solvent and ejected into a desired vascular site is found in Park et al. U.S. patent application Ser. No. 08/734,442 filed Oct. 17, 1996 for xe2x80x9cLIQUID EMBOLIC AGENTSxe2x80x9d. Other materials such as hog hair and suspensions of metal particles have also been suggested and used by those wishing to form occlusions.
Other materials including polymer resins, typically cyanoacrylates, are also employed as injectable vaso-occlusive materials. These resins are typically mixed with a radio-opaque contrast material or are made radio-opaque by the addition of a tantalum powder. Their use is fraught with problems in that placement of the mixture is quite difficult. These materials may crosslink with the human body. Inadvertent embolisms in normal vasculature (due to the inability of controlling the destination of the resins) is not uncommon. The material is also difficult or impossible to retrieve once it has been placed in the vasculature.
Over the past few years, advancements in the artificial occlusion of vessels and aneurysms have included the delivery and implantation of metal coils as vaso-occlusive devices. Implantable metal coils that are useful as artificial occlusion devices in vasculature lumens or aneurysms are herein referred to as xe2x80x9cvaso-occlusions coils.xe2x80x9d
Vaso-occlusion coils are generally constructed of a wire, usually made of a metal or metal alloy, that is wound to a helix. Many such devices are introduced to the selected target site through a catheter in a stretched linear form. The vaso-occlusive device assumes an irregular shape upon discharge of the device from the distal end of the catheter a variety of vaso-occlusive coils and braids are known. For instance, U.S. Pat. No. 4,994,069, to Ritchart et al. shows a flexible, preferably coiled, wire for use in small vessel vaso-occlusion. Unlike vaso-occlusive coils used prior to that time, Ritchart et al taught a coil which is fairly soft and is delivered to the site using a pusher within a catheter lumen. Upon discharge from the delivery catheter, the coil may undertake any of the number of random or regular configurations used to fill the site. The coils may be used for small vessel sites, e.g., 0.5-6 mm in diameter. The coils themselves are described as being between 0.010 and 0.030 inches in diameter. The length of the coil wire is typically 15 to 20 times the diameter of the vessel to be occluded. The wire used to make up the coils may be, for instance, 0.002 to 0.006 inches in diameter. Tungsten, platinum, and gold threads or wires are said to be preferred. These coils have a variety of benefits including the fact that they are relatively permanent, they may be easily imaged radiographically, they may be located at a well defined vessel site, and they can be retrieved.
It is common that these vaso-occlusive devices be delivered through micro atheters such as the type disclosed in U.S. Pat. No. 4,739,768, to Engelson. These microcatheters track a guidewire to a point just proximal or within the desired site for occlusion. The coil is advanced through the microcatheter (once the guidewire is removed) and out the distal end hole so to at least partially fill the selected space and create an occlusion.
In addition to vaso-occlusion devices or coils having predetermined secondary shapes that dictate in part their space filling mechanism, other vaso-occlusive coils have been disclosed that take on random shapes when expelled from a delivery sheath. One such type is a vaso-occlusive coil often referred to as xe2x80x9ca liquid coilxe2x80x9d. One example of such a vaso-occlusive coil is disclosed in pending U.S. patent application Ser. No. 08/413,970, filed Mar. 30, 1995. This describes a very soft and flexible coil which is flow-injectable through a delivery catheter using, e.g., saline solution.
In addition to the various types of space filling mechanisms and geometries of vaso-occlusive coils, other particularized features of coil designs, such as mechanisms for delivering vaso-occlusive coils through delivery catheters and implanting them in a desired occlusion site, have also been described. The examples of categories of vaso-occlusive coils based upon their delivery mechanisms include pushable coils, mechanically detachable coils, and electrolytically detachable coils.
One example of the type of vaso-occlusive coil referred to above as the xe2x80x9cpushable coilxe2x80x9d is disclosed in Ritchart et al., discussed above. Pushable coils are commonly provided in a cartridge and are pushed or xe2x80x9cplungedxe2x80x9d from the cartridge into a delivery catheter lumen pusher advances the pushable coil through and out of the delivery catheter lumen and into the site for occlusion.
Mechanically detachable vaso-occlusive devices are typically integrated with a pusher rod and are mechanically detached from the distal end of that pusher after exiting a delivery catheter. Examples of such mechanically detachable vaso-occlusive coils are found in U.S. Pat. No. 5,261,916 to Engelson or U.S. Pat. No. 5,250,071 to Palermo.
Finally, examples of electrolytically detachable vaso-occlusive devices may be found in U.S. Pat. Nos. 5,122,136 and 5,354,295, each to Guglielmi et al. In these devices, the vaso-occlusive portion of the assembly is attached to a pusher via a small, electrolytically severable joint. The electrolytically severable joint is severed by the placement of an appropriate voltage on the core wire. The joint erodes in preference either to the vaso-occlusive device itself or to the pusher core wire. The core wire is often simply insulated to prevent the electrolytic response caused by the imposition of electrical current.
Further improvement upon the electrolytically detachment mechanism described just is found in U.S patent application Ser. No. 08/205,512, filed Mar. 3, 1994, for xe2x80x9cIMPLANT DETACHMENT DETECTION SYSTEM AND METHOD FOR DETECTING SEPARATION OF VASO-OCCLUSIVE DEVICESxe2x80x9d. This document described a procedure for superimposing a modest alternating current upon the direct current signal. A sensing circuit monitors the alternating current as an indicator of the progression of coil detachment.
Improvements in enhancing the thrombogenic or other occlusive tissue response to metal coils has also been disclosed. For example, vaso-occlusive coils having fibers attached thereto are knownxe2x80x94see, for example, U.S. Pat. No. 5,226,911, to Chee et al.
Each of the devices described above may be used in the treatment by occlusion of aneurysms. As noted above, aneurysms present particularly acute medical risk due to the dangers of potential rupture of the thin wall inherent in such aneurysm. Occlusion of aneurysms by use of vaso-occlusive coils without occluding the adjacent artery is a special challenge and is a desirable method of reducing such risk of rupture.
As noted above, the use of vaso-occlusive coils in treating aneurysms is widespread. These vaso-occlusive devices are placed in an aneurysm in the following fashion. A microcatheter is initially steered into or adjacent to the entrance of an aneurysm, typically aided by the use of a steerable guidewire. The wire is then withdrawn from the microcatheter lumen and replaced by the vaso-occlusive coil. The vaso-occlusive coil is advanced through and out of the microcatheter, desirably being completely delivered into the aneurysm. After, or perhaps, during, delivery of such a coil into the aneurysm, there is a specific risk that a portion of the coil might migrate out of the aneurysm entrance zone and into the feeding vessel. The presence of such a coil in that feeding vessel may cause the highly undesirable response of causing an occlusion there. Also, there is a quantifiable risk that the blood flow in the vessel and aneurysm may induce movement of the coil farther out of the aneurysm, resulting in a more developed embolus in the patent vessel.
One type of aneurysm, commonly known as a xe2x80x9cwide neck aneurysmxe2x80x9d is known to present particular difficulty in the placement and retention of vaso-occlusive coils. Wide neck aneurysms are herein referred to as aneurysms of vessel walls having a neck or a xe2x80x9centrance zonexe2x80x9d from the adjacent vessel, which entrance zone has a diameter that either: (1) is at least 80% of the largest diameter of the aneurysm; or (2) is clinically observed to be too wide effectively to retain vaso-occlusive coils that are deployed using the techniques discussed above.
Furthermore, vaso-occlusive coils lacking substantial secondary shape strength may be difficult to maintain in position within an aneurysm no matter how skillfully they are placed.
There are few disclosed devices for maintaining the presence of vaso-occlusive coils within an aneurysm. One such device is shown in U.S. patent application Ser. No. 08/690,183, filed Jul. 26, 1996, for xe2x80x9cANEURYSM CLOSURE DEVICE ASSEMBLYxe2x80x9d. That application describes devices which are said to be placed within the lumen of a feed vessel exterior to the aneurysm so to retain coils within the aneurysm cavity. That is to say that the retainer device is released in the good vessel exterior to the aneurysm. The device is held in place via the use of radial pressure on the vessel wall. After the device is released and set in an appropriate place, a microcatheter is inserted into the lumen behind the retainer device; the distal end of the catheter is inserted into the aneurysm cavity. One or more vaso-occlusive devices is introduced into the aneurysm cavity. The retainer device maintains the presence of those vaso-occlusive devices within the aneurysm no matter whether the aneurysm is a large mouth aneurysm or not.
Another device for closing an aneurysm is found in U.S. patent application Ser. No. 08/588,195 filed Jan. 18, 1996, for xe2x80x9cANEURYSM CLOSURE METHODxe2x80x9d. In this procedure, a vaso-occlusive device such as a coil or braid has on its outer surface a polymeric composition which may be reformed or solidified in situ within the human body. The device is simply inserted into the aneurysm and the polymer is then reformed, e.g., by the application of light to melt or otherwise reform the polymer exterior to the vaso-occlusive device. The vaso-occlusive device then sticks to itself at the various sites of self-contact and forms a rigid whole mass within the aneurysm.
There are a variety of other vaso-occlusive coils and devices which may be specified herein. The material provided above is only exemplary of the patents and publications dealing with such devices. No coil retainer device of the structure described herein is seen in any of the references described above.
This invention includes an implantable medical device useful for retaining other occlusion device at an occlusion site, such as an aneurysm, and related methods of introducing and installing that implantable retainer at the occlusion site. Combinations of the retainer device and its included vaso-occlusive material or device are also an aspect of the invention as are combinations of the retainer device and its delivery components. In particular, the invention involves an implantable retainer which is deliverable through an elongated tubular delivery device such as a vascular catheter. The assemblage includes an implantable retainer which is placed in and allowed to remain in an aneurysm and a tubular delivery member to which it is attached by an electrolytically severable joint. In general, the implantable retainer component may either extend from the distal end of the tubular delivery member or may include a small tubular section which in turn is slipped over the distal end of the delivery component.
The joint itself is electrolytically severable upon application of a suitable current to the joint, typically by use of a conductor wire which may be placed in the wall of the delivery member. The joint is comparatively more electrolytically dissolvable when a current is applied than are any of the rest of the components which surround or deliver it. The retainer component itself has a number of array elements shaped preferably the general shape of flower petals in a flower. The array elements may either be exterior wires or regions having exterior wires and covered with a mesh of some kind. The petals or array elements have a primary shape when inside the delivery tubular member and then assume a secondary shape upon exit from the distal end of that delivery tubular member. Once the retainer subassembly containing the array elements is in place, the vaso-occlusive device, e.g. vaso-occlusive coils, may be introduced into the aneurysm either through the small tubular member to which the array members are attached or, if the array members do not have a mesh covering, through the open area found at the neck of the aneurysm.